Triathlon 5566-S-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026283), received between Sep 24, 2019 and Feb 21, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2022Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED BY PATIENT'S WIFE, PATIENT HAD A RIGHT TKA ON 2010 (APPROX). WITHIN A YEAR OF THE SURGERY PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING. THE PATIENT FOLLOWED UP WITH HIS SURGEON AND WAS TOLD HE HAD AN INFECTION AND WAS REVISED ON 2012 (APPROX). THE PATIENT WAS IMPLANTED WITH AN ANTIBIOTIC SPACER AND APPROX 3-5 MONTHS LATER THE PATIENT WAS IMPLANTED. EARLY THIS YEAR THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6) 2021 THE PATIENT FOLLOWED UP WITH HIS SURGEON WHERE AN X-RAY WAS TAKEN AND WAS TOLD THAT HIS IMPLANT WAS CRACKED. THE SURGEON RECOMMENDED REVISION. PATIENT WOULD LIKE SOME ASSISTANCE WITH MEDICAL BILLS AND REVISION SURGERY. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR PAIN AND CRACK/FRACTURE AFTER REVISION UPDATE: "NEW SURGERY THAT HAPPENED (B)(6), TO REPLACE THE CRACKED PROSTHETIC."

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fibrosis; Inflammation; Pain

  MAUDE report 13567796 ↗
• InjurySep 24, 2019Break; Fracture; Material Fragmentation; Osseointegration Problem; Break; Fracture; Material Fragmentation; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF SHARP TIBIAL PAIN. THE ORIGINAL SURGICAL PLAN WAS TO PERFORM A POLY SWAP. INTRA-OPERATIVELY, THE SURGEON NOTED THE PRESENCE OF BLACK, METALLIC DEBRIS IN THE PATIENT. THE SURGEON FOUND THE TIBIAL COMPONENT WAS LOOSE AND THAT THE DEVICE HAD BROKEN AT THE STEM/ BASEPLATE JUNCTION. THE PATIENT WAS REVISED TO ANOTHER UNIVERSAL BASEPLATE WITH STEM AND INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE INSERT, AND THAT THE FEMORAL COMPONENT WAS WELL-FIXED AND NOT REVISED. REP PROVIDED PRE-REVISION X-RAYS AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9111376 ↗